It has been known to administer pharmaceutically active agents in an edible film vehicle.
For example, WO 99/17753 discloses rapidly dissolving films for delivery of drugs to be adsorbed in the digestive tract.
WO 98/26780 discloses a flat, foil, paper or wafer type presentation for the application and release of active substances in the buccal cavity. The specific active ingredient disclosed in WO 98/26780 is buprenorphine.
WO 98/20862 discloses a film for use in the oral cavity that can contain a cosmetic or pharmaceutical active substance.
WO 98/26763 discloses a flat, foil, paper or wafer like presentation for release of active substances into the buccal cavity. The particular active disclosed is apomorphine.
U.S. patent application Ser. No. 09/395,104 also discloses the delivery of pharmaceutical agents in a edible film vehicle.
U.S. Pat. No. 5,411,945 to Ozaki et al. discloses a pullulan binder and products produced therewith, including edible films (Example B-2). The products can include a variety of ingredients in addition to pullulan, such as other polysaccharides, antibacterial agents, flavor-imparting agents and pharmaceutically active substances (column 4, lines 5–15).
U.S. Pat. No. 3,784,390 Hijiya et al. discloses pullulan films and their use in coating and packing materials for foods, pharmaceuticals and other oxygen sensitive materials. All of the examples in this patent teach mixing pullulan in hot water.
It has also been known to combine ion exchange resins with pharmaceutically active agents to provide sustained release formulations.
For example, U.S. Pat. No. 6,001,392 to Wen et al. discloses a controlled-release syrup suspension for oral administration containing dextromethorphan adsorbed to a polystyrene sulfonate ion exchange resin. Pharmaceutical films are not disclosed.
U.S. Pat. No. 5,980,882 to Eichman discloses a method for improving the stability of a pharmaceutical composition that contains a drug-resin complex, comprising adding a chelating agent in an amount effective to reduce the rate of degradation of the drug in the drug-resin complex. Although Eichman teaches that complexing a drug with an ion exchange resin can mask the taste of the drug. Pharmaceutical films are not disclosed.
The inventors are not aware of any suggestion in the published art that ion exchange resins can act as taste masking agents in a fast dissolving orally consumable film. Accordingly, an object of this invention is to provide fast dissolving orally consumable films containing an ion exchange resin to mask the taste of a pharmaceutically active agent therein.
All references cited herein are incorporated herein by reference in their entireties.